Pharmacokinetics of Micafungin in Critically Ill Patients

Sponsor

University Medical Center Groningen (Other)

Overall Status

Completed

CT.gov ID

NCT01716988

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A study of micafungin in ICU versus non-ICU patients showed a significantly lower treatment success in ICU patients compared with non-ICU patients. It is known that in critically ill patients, alterations in function of various organs and body systems can influence the pharmacokinetics and hence the plasma concentration of a drug. The pharmacokinetic parameters of micafungin in critically ill patients are most likely different, but this has not been specifically studied.

The pharmacokinetic parameters of micafungin in critically ill patients will be established and plasma concentrations of micafungin will be correlated with disease severity.

Condition or Disease	Intervention/Treatment	Phase
Critical Illness Invasive Candidiasis

Study Design

Study Type:

Observational

Actual Enrollment :

19 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Pharmacokinetics of Micafungin in Critically Ill Patients With Invasive Candidiasis

Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Micafungin

Outcome Measures

Primary Outcome Measures

Correlation of pharmacokinetic parameters/plasma concentrations of micafungin with disease severity. [4 days]
Correlation of the level of micafungin concentration with disease severity scores. Correlation of pharmacokinetic parameters (clearance, half-life) of micafungin with disease severity scores.

Secondary Outcome Measures

Pharmacokinetic parameters of micafungin in ICU patients. [4 days]
Calculate the pharmacokinetic parameters (clearance, half life, volume of distribution) of micafungin.
Time (in days) to culture conversion. [max 28 days]
Number of days untill cultures are negative.
Correlation of the plasma concentration of micafungin with response to treatment. [max 28 days]
Correlation of the level of micafungin concentration with outcome.
Correlation of the plasma concentration of micafungin with inflammation parameters. [4 days]
Correlation of the level of micafungin concentration with interleukin-6, interleukin-8 and procalcitonin.
Area under the concentration-time curve (AUC)/minimal inhibitory concentration (MIC) ratio. [max 28 days]
Area under the concentration-time curve of micafungin devided by the minimal inhibitory concentration of the candida species.
Composing a pharmacokinetic model of micafungin in critically ill patients. [max 28 days]
Composing a pharmacokinetic model of micafungin to estimate the 24-hours AUC of micafungin based on limited samples.
Highest observed plasma concentration (Cmax)/minimal inhibitory concentration (MIC) ratio. [28 days]
Highest observed plasma concentration of micafungin devided by the minimal inhibitory concentration of the candida species.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Treatment with micafungin.
Admission to an ICU.
Age ≥ 18 years.
Invasive candidiasis.

Exclusion Criteria:

Blood sampling not possible.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center Groningen	Groningen		Netherlands	9700 RB

Sponsors and Collaborators

University Medical Center Groningen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jan-Willem C Alffenaar, PharmD, PhD, University Medical Center Groningen

ClinicalTrials.gov Identifier:

NCT01716988

Other Study ID Numbers:

NL39246.042.12

First Posted:

Oct 30, 2012

Last Update Posted:

Jan 12, 2017

Last Verified:

Jan 1, 2017

Keywords provided by Jan-Willem C Alffenaar, PharmD, PhD, University Medical Center Groningen

Additional relevant MeSH terms:

Candidiasis

Candidiasis, Invasive

Critical Illness

Study Results

No Results Posted as of Jan 12, 2017